BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

    MDR report key: 7484976 · Received May 3, 2018

    Report

    Report Number
    9617032-2018-00841
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    August 3, 2017
    Report Date
    June 12, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE TYPE CORRECTED TO JKA. PMA / 510(K)# CORRECTED TO K991120.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. NO LOT # PROVIDED. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. DEVICE MANUFACTURE DATE: UNKNOWN. RESULT: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® CTAD BLOOD COLLECTION TUBES WERE HAVING FM INSIDE THE PLASMA, NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325488 BD VACUTAINER® CTAD BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other